Company

Pharma

RegulatoryAffairsandPatientSafetyTalentPool

€65–95k ~AI est. Ireland FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“Regulatory Affairs and Patient Safety Talent Pool. Skills: Regulatory Affairs, Patient Safety, Pharmacovigilance, Regulatory strategy. Support regulatory affairs activities. Contribute to regulatory strategy development”

What You'll Achieve.

Improve patient outcomes

Industry & Context.

Pharma
Problems you'll solve

Analytical skills; Interpret complex regulatory information

What They're Looking For.

Must Have

Experience in Regulatory Affairs, Experience in Pharmacovigilance, Experience in Patient Safety, Experience in pharmaceutical industry, Experience in life sciences industry, Understanding of regulatory frameworks, Understanding of submission processes, Understanding of safety reporting requirements, Familiarity with global regulatory environments, Familiarity with compliance standards, Analytical skills, Ability to interpret complex regulatory information, Ability to work independently, Ability to manage multiple priorities

Nice to Have

Knowledge of labeling, Knowledge of regulatory operations, Knowledge of CMC, Knowledge of health authority interactions, Bachelor’s degree in life sciences, Bachelor’s degree in pharmacy, Bachelor’s degree in medicine

What You'll Do.

Support regulatory affairs activities

Contribute to regulatory strategy development

and Controls (CMC) activities

Participate in regulatory operations processes

Support patient safety activities

Ensure compliance with international regulatory standards

Ensure compliance with pharmacovigilance standards

Ensure timely execution of regulatory deliverables

Ensure accurate execution of regulatory deliverables

Ensure timely execution of safety deliverables

Ensure accurate execution of safety deliverables

How You'll Work.

Team & Collaboration

Global cross-functional teams

Full Job Description

## Accountabilities Support regulatory affairs activities across multiple domains, including labeling operations, regulatory submissions, publishing, and compliance documentation. Contribute to regulatory strategy development for product labeling, advertising, promotion, and lifecycle management. Assist in Chemistry, Manufacturing, and Controls (CMC) activities, ensuring alignment with regulatory requirements and product quality standards. Participate in regulatory operations processes, including dossier preparation, submission tracking, and health authority interactions. Support patient safety activities, including monitoring, documenting, and analyzing safety events and adverse trends. Collaborate with global cross-functional teams to ensure compliance with international regulatory and pharmacovigilance standards. Ensure timely and accurate execution of regulatory and safety deliverables in alignment with global project requirements. Requirements: Experience in Regulatory Affairs, Pharmacovigilance, or Patient Safety within the pharmaceutical or life sciences industry. Strong understanding of regulatory frameworks, submission processes, and/or safety reporting requirements. Knowledge of labeling, regulatory operations, CMC, or health authority interactions is highly valued depending on specialization. Familiarity with global regulatory environments and compliance standards. Strong analytical skills with attention to detail and ability to interpret complex regulatory information. Excellent communication and collaboration skills in a global, cross-functional environment. Ability to work independently in remote or hybrid environments while managing multiple priorities. Bachelor’s degree in life sciences, pharmacy, medicine, or related field preferred. Benefits: Opportunity to be considered for multiple global regulatory and patient safety roles Remote-friendly opportunities depending on assignment Exposure to international regulatory frameworks and global healthcare

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